FDA.reportPublic FDA data

Application 077652

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET;ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET;ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET;ORAL750MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077652-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-09-07
A077652-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-09-07
A077652-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077652-001AB
A077652-002AB
A077652-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07a50c72e98297…
2026-08-01 22:54:322026-06A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07a50c72e98297…
2026-08-01 22:54:322026-06A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077652-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077652-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077652-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
application applno (ANDA): 077652
application number: ANDA077652
ndc (product): 65841-691
ndc (product): 65841-692
ndc (product): 65841-693
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
ndc (product): 72578-100
ndc (product): 72578-098
ndc (product): 72578-099
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-451levofloxacinlevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
42708-063levofloxacinlevofloxacinQPharma IncANDACurrent
50090-2540levofloxacinlevofloxacinA-S Medication SolutionsANDACurrent
50090-2736levofloxacinlevofloxacinA-S Medication SolutionsANDACurrent
58118-1016levofloxacinlevofloxacinClinical Solutions Wholesale, LLCANDACurrent
58118-1016levofloxacinlevofloxacinClinical Solutions Wholesale, LLCANDACurrent
63187-514levofloxacinlevofloxacinProficient Rx LPANDACurrent
63187-514levofloxacinlevofloxacinProficient Rx LPANDACurrent
63187-514levofloxacinlevofloxacinProficient Rx LPANDACurrent
63629-7050levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
63629-7050levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
65841-691levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-691levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-691levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-691levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-691levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-692levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-692levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-692levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-692levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-692levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-693levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-693levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-693levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-693levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
65841-693levofloxacinlevofloxacinCadila Healthcare LimitedANDACurrent
67296-1119levofloxacinlevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1119levofloxacinlevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1123levofloxacinlevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1123levofloxacinlevofloxacinRedPharm Drug, Inc.ANDACurrent
68382-015levofloxacinlevofloxacinZydus Pharmaceuticals (USANDACurrent
68382-015levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-015levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-015levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-016levofloxacinlevofloxacinZydus Pharmaceuticals (USANDACurrent
68382-016levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-016levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-016levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-017levofloxacinlevofloxacinZydus Pharmaceuticals (USANDACurrent
68382-017levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-017levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-017levofloxacinlevofloxacinZydus Pharmaceuticals (USA) Inc.ANDACurrent
71335-0428levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
71335-0428levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
71335-0428levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
72578-098levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent
72578-098levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent
72578-099levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent
72578-099levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent
72578-100levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent
72578-100levofloxacinlevofloxacinViona Pharmaceuticals IncANDACurrent